Anterior Pelvic Prolapse Reconstruction With TiLOOP® Total 6 - Full Text View

Sponsor:	pfm medical ag
Collaborators:	Aix Scientifics GfE Medizintechnik GmbH
Information provided by (Responsible Party):	pfm medical ag
ClinicalTrials.gov Identifier:	NCT01084889

Purpose

The purpose of this study is to determine the influence of Anterior Pelvic Prolapse Reconstruction with a titanised polypropylene mesh on rate of erosion and patients quality of live.

Condition	Intervention
Cystocele Uterine Prolapse	Device: TiLOOP® Total 6 (Surgical mesh implantation)

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	National, Multicentre Post-marketing Surveillance Study on Anterior Pelvic Prolapse Reconstruction With Titanium-coated Polypropylene Mesh (TiLOOP® Total 6)

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Support Problems

U.S. FDA Resources

Further study details as provided by pfm medical ag:

Primary Outcome Measures:

Erosion rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Erosion, in the sense of the end point, is any erosion requiring more than simply the cut off of a single short filament.
Patient's quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
It will be shown that by means of a validated questionnaire whether the subjective quality of life after 6 months is significantly better than before implantation.

Secondary Outcome Measures:

Adverse Events [ Time Frame: at 6, 12, 36 months ] [ Designated as safety issue: Yes ]
Feasibility of the mesh implantation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Erosion rate [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Erosion, in the sense of the end point, is any erosion requiring more than simply the cut off of a single short filament.
Patient's quality of life [ Time Frame: 12 and 36 months ] [ Designated as safety issue: No ]
It will be shown that by means of a validated questionnaire whether the subjective quality of life after 6 months is significantly better than before implantation.

Estimated Enrollment:	230
Study Start Date:	April 2010
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
symptomatic genital descensus Women with a symptomatic genital descensus : at least stage II (ICS-classification according POP-Q system), or stage I with a symptomatic requiring intervention.	Device: TiLOOP® Total 6 (Surgical mesh implantation) The standard procedure for the surgical repair of anterior prolapse is via the obturator membrane. The mesh is placed trans vaginal by the aid of surgical instruments to place the mesh arms. Other Name: TiLOOP® Total 6

Detailed Description:

This multicentre, non-randomised, observational clinical device investigation will be performed to obtain post-marketing information on the TiLOOP® pelvic floor reconstruction meshes and in particular on the rate of rare erosions of the device under investigation as well as on the improvement of patients' quality of life. It is expected that the rate of erosions is equal or lower compared to competitor devices currently on the market. To verify this, it will be shown that within the first year the erosion rate found for the product under investigation is in the range of 7.9 ± 5.4 %, which is the mean erosion rate found in the recent literature. Erosion, in the sense of the hypothesis, is any erosion 1 requiring more than simply the cut off of a single short filament.

It is also expected that the patient's quality of life is meliorated after implantation of a TiLOOP® Total 6 mesh. To verify this, it will be shown that by means of a validated questionnaire the subjective quality of life after 6 months is significantly better than before implantation.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Women with a symptomatic genital descensus treated in the center

Criteria

Inclusion Criteria:

Women with a symptomatic genital descensus : at least stage II (ICS-classification according POP-Q system), or stage I with a symptomatic requiring intervention. This applies to primary as well as recurrent intervention
Existence of a cystocele.
Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation
Patient information has been handed out and all written consents are at hand.
Patient has attained full age.

Exclusion Criteria:

Pregnancy or unfinished family planning.
Known intolerance to the mesh-implants under investigation.
Patients with acute (last 12 months) carcinoma.
Patients with history of radiotherapy in the pelvic area.
Genital descensus without any complaints.
Patients with implanted pelvic floor mesh.
Systemic steroid treatment.
Lack of written patients' informed consent.
Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol.
Patient is institutionalised by court or official order (MPG §20.3).
Participation in another clinical investigation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084889

Contacts

Contact: Lutz H Sternfeld, Dr.

+49 2236 9641 ext 149

lutz.sternfeld@pfmmedical.com

Locations

Germany
Berliner Kontinenzzentrum am Franziskus Krankenhaus,	Active, not recruiting
Berlin, Germany, 10787
Krankenhaus Dresden- Friedrichsstadt	Recruiting
Dresden, Germany, 01067
Contact: Markus Grebe, Dr. Md +49 351 480 ext 1620
Principal Investigator: Markus Grebe, Dr. Md
Sub-Investigator: Galia Cisternas, Dr. MD
Evangelisches Diakoniekrankenhaus Freiburg	Recruiting
Freiburg, Germany
Contact: Dirk Waterman, MD +49 7761 1301 ext 244
Principal Investigator: Dirk Watermann, Prof. Dr. (MD)
Sub-Investigator: Rudolf Seiter, Dr. (MD)
Universitätsklinikum Eppendorf	Active, not recruiting
Hamburg, Germany, 20246
St. Elisabeth Krankenhaus Leipzig,	Recruiting
Leipzig, Germany, 04277
Contact: Birgit Henne, Dr. MD
Principal Investigator: Birgit Henne, Dr. MD
Regionale Kliniken Holding RKH GmbH, Klinikum Ludwigsburg	Recruiting
Ludwigsburg, Germany, 71640
Contact: Jan Kaufhold, Dr. Md +49 7141 99 ext 67659
Principal Investigator: Jan Kaufhold, Dr. Md
Beckenbodenzentrum München	Completed
München, Germany, 81679
Waldburg-Zeil Kliniken, Klinik Tettnang	Recruiting
Tettnang, Germany, 88069
Contact: Christian Fünfgeld, Dr. MD
Principal Investigator: Christian Fünfgeld, Dr. MD
Principal Investigator: Margit Stehle, MD
Klinikum Oberlausitzer Bergland gGmbH,	Recruiting
Zittau, Germany, 02763
Contact: Mathias Mengel, Dr. MD
Principal Investigator: Mathias Mengel, Dr. MD

Sponsors and Collaborators

pfm medical ag

Aix Scientifics

GfE Medizintechnik GmbH

Investigators

Principal Investigator:

Christian Fünfgeld, Dr. MD

Waldburg-Zeil Kliniken

More Information

No publications provided

Responsible Party:	pfm medical ag
ClinicalTrials.gov Identifier:	NCT01084889 History of Changes
Other Study ID Numbers:	pfm 10k001 TiLOOP® Total 6
Study First Received:	March 10, 2010
Last Updated:	January 2, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by pfm medical ag:

polypropylene mesh
Prolapse
Cystocele
Surgical Mesh

Additional relevant MeSH terms:

Cystocele
Prolapse
Uterine Prolapse
Urinary Bladder Diseases
Urologic Diseases

Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on February 09, 2012